FDA Product Code INI: Vehicle, Motorized 3-wheeled
Three-wheeled motorized vehicles provide enhanced outdoor mobility for people with physical disabilities. FDA product code INI covers motorized three-wheeled mobility vehicles cleared as medical devices.
These scooter-style devices use a battery-powered motor and tiller steering to provide independent mobility for individuals who can sit upright but cannot walk distances. They offer greater stability on uneven terrain than four-wheeled scooters due to their turning radius.
INI devices are Class II medical devices, regulated under 21 CFR 890.3800 and reviewed by the FDA Physical Medicine panel.
Leading manufacturers include Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, Heartway Medical Products Co., Ltd. and Intradin (Shanghai) Machinery Co., Ltd..
FDA 510(k) Cleared Vehicle, Motorized 3-wheeled Devices (Product Code INI)
About Product Code INI - Regulatory Context
510(k) Submission Activity
344 total 510(k) submissions under product code INI since 1982, with 344 receiving FDA clearance (average review time: 118 days).
Submission volume has increased in recent years - 31 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under INI have taken an average of 141 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.
INI devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →